Übersicht

ITM Oncologics GmbH
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM).

We would like to fill the following vacancy as soon as possible:
Early Clinical Development Lead (f/m/d)
ITM Oncologics is growing rapidly. This is an ideal opportunity for an ambitious clinical development physician to be a part of this evolving company. This is a key role within the medical group reporting to the Head of Clinical Development. The successful candidate will be expected to develop his/her team to lead the transition of early products from preclinical to their clinical development in Phase I/II.
Member of the medical team, with key role leading the translation of compounds from the late preclinical stage of drug discovery to the design and execution of early clinical development plans
Develop and lead the early clinical development team
Interact closely with preclinical development in translating compounds through the lead identification and candidate validation stage gates
Develop translational medicine/Phase I strategy for candidate compounds
Lead the design of Phase I/II clinical study protocols and clinical study reports, according to current international regulations and guidelines
Support strategic development of the company with the identification and assessment of new early opportunities, with participation in due diligence activities
Lead the organization and running of national and/or international expert consultations and multidisciplinary advisory boards
Contribute to the publications related to clinical data and presentation of results at internal and external meetings
As a member of the medical team providing clinical pharmacology input to late stage clinical studies
Ensure integrity of data and interpretation of clinical study results
Monitor safety of compounds in clinical development, with participation in safety monitoring boards
Lead the clinical pharmacology interactions with regulatory authorities (e.g. Investigator Brochures, regulatory dossiers, scientific advice meetings, answering List of Questions)

Doctor of medicine or radiopharmacist, preferably with clinical experience in nuclear medicine
Solid experience in managing early clinical development of new chemical entities (clinical pharmacology, PK/PD, dosimetry, dose finding, Phase 1/2 clinical studies) and translational medicine; experience in radiotheranostic development would be a distinct advantage
Solid background in the development of Phase I/II clinical study protocols and study reports including sound knowledge of early development methodology and design (basket studies, adaptive designs, etc.)
Strategic mindset, with previous experience in early due diligence activities
Sound knowledge of ICH-GCP and other relevant regulations/guidelines
Experience in interacting with regulatory authorities
Experience in drug safety and working with pharmacovigilance
Demonstrated expertise in ability to lead complex medical and scientific discussions and synthesize and communicate information clearly
Demonstrated leadership experience, with ability to work in a medium-size company with a matrix non-hierarchical environment

A modern workplace and exciting opportunities in an evolving and fast growing company
Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
A collegial corporate culture and short communication channels